Method for identifying the presence of abnormal tissue

• US 4,428,382 A
• Filed: 01/27/1982
• Issued: 01/31/1984
• Est. Priority Date: 09/03/1980
• Status: Expired due to Fees

• Current Assignee: GST Laboratories, Inc.
• Original Assignee: GST Laboratories, Inc.
• Inventors: Vincent, James R., Walsall, E. Peter T.
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): Sykes, Angela D.
• Application Number:
  US06/343,389
• Time in Patent Office: 734 Days
• Field of Search: 128/736, 128/1 R, 364/414-415
• US Class Current: 600/549
• CPC Class Codes: A61B 5/015 By temperature mapping of body part

Abstract

A method for the (i) sequential acquisition of temperature measurements of predetermined parts of a living body, obtained under standardized conditions, both before and after the administration of a specific body stress; (ii) sampling such data to select the most representative data points, (iii) manipulating the selected data by identifying temperature asymmetries, and making certain correlative comparisons, among other manipulations; for the purpose of obtaining an objective indication of the probable presence and location of normal or diseased tissue; and (iv) providing a relatively simple quantitative measure of such indication.

Claims

1. An objective quantitative method for identifying tissue suspected of being abnormal in at least a first portion of the body of a living organism, the method comprising the steps of:

(a) providing means for storing data;

(b) measuring the static temperature of at least one area of a second portion of said body by thermally responsive measurement means and storing the same in said storage means, said second portion body temperature being responsive to general temperature changes in said body and serving as a first reference temperature;

(c) dividing said first body portion into a plurality of imaginary radial sectors extending from a central sector;

(d) measuring the static temperatures of said first body portion at least once at a plurality of points within each of said sectors to provide a plurality of temperatures for each sector relative to said first reference temperature thereby producing a static scan over each sector of said first body portion, said measurement being taken with said measurement means;

(e) determining a first average static temperature for each sector from the plurality of sector temperatures;

(f) storing the plurality of average static sector temperatures and the sectors of said first body portion to which they relate in said storage means;

(g) storing an average static temperature for said first body portion determined from said plurality of average static sector temperatures in said storage means;

(h) correlating said first average static sector temperatures to a corresponding set of expected static sector temperatures pre-stored in said storage means, wherein said expected static sector temperatures are prior temperature measurements made of said first body portion and adjusted for physiological changes;

(i) administering a stress to said body;

(j) remeasuring the temperature of at least one area of said second body portion after said stress, said remeasured temperature serving as a second reference temperature;

(k) remeasuring the temperatures of said first body portion at least once at a plurality of points within each of said sectors to provide a plurality of temperatures for each sector during said stress relative to said second reference temperature, said remeasurement being taken with thereby producing a stress scan over each sector of said first body portion, said measurement means;

(l) determining a second average temperature for each sector from the plurality of temperatures measured during the stress scan;

(m) storing the plurality of second average sector temperatures from said stress scan and the sectors of said first body portion to which they relate in said storage means;

(n) storing an average temperature for said first body portion determined from said plurality of second average sector temperatures measured during said stress scan and stored in said storage means;

(o) correlating said plurality of second average sector temperatures from said stress scan to a corresponding set of said expected static sector temperatures pre-stored in said storage means, wherein said expected static sector temperatures are prior temperature measurements made of said first body portion adjusted for physiological changes;

(p) providing means for selectively displaying objective data;

(q) selectively providing as output on said display means said first average static sector temperatures and said first reference temperature and said second average sector temperatures and said second reference temperature to provide a temperature topological profile of said first body portion;

(r) determining from said temperature topological profile the probability that any of said sectors in said first body portion contains abnormal tissue.

2. The method of claim 1 wherein said stress is administered by physiologically cooling said body.

3. The method of claim 2 wherein said physiological cooling is achieved by placing at least one extremity of said body in icewater for a predetermined period of time.

4. The method of claim 3 wherein said stress scan temperature measurements are started at least ninety seconds after removal of the at least one extremity from said ice water.

5. The method of claim 1 wherein said organism is a human being, and said second body portion is the forehead thereof.

6. The method of claim 5 wherein the difference between said first reference temperature of said second body portion and said second reference temperature of said second body portion comprises a decrease in temperature occurring during an interval of one to ten minutes following said stress.

7. The method of claim 1 wherein said thermally responsive measurement means is an instrument having a detector which is sensitive to either microwave or infrared radiation.

8. The methods of claim 7 wherein said probability is determined by:

(i) measuring the difference between an average static forehead temperature and the average right breast static temperature;

(ii) measuring the difference between the average static forehead temperature and the average left breast static temperature;

(iii) providing means for summing the differences in steps i and ii together;

(v) generating a correlation parameter by correlating the average right breast temperature to a corresponding set of expected right breast temperatures prestored in said storage means, and correlating the average left breast temperature to a corresponding set of expected left breast temperatures prestored in said storage means;

(v) generating a basic parameter which provides the greatest discrimination between normal and abnormal tissue utilizing the sum from step iii and the correlation parameter;

(vi) determining the average breast temperature from said plurality of average sector temperatures for each breast and storing said average breast temperature in said storage means during said stress scan and said static scan;

(vii) measuring the difference between the average right breast temperature and the average left breast temperature for the static scan and the stress scan to provide a worst breast average asymmetry;

(viii) measuring the maximum difference between the average sector temperature of the right breast and the corresponding average temperature of its mirror image counterpart sector of the left breast corrected for expected temperatures based on statistical averages attributable to cup size differential and difference in blood flow due to cardiac proximity to provide contralateral asymmetry;

(ix) providing determining means for determining the number of breast sectors whose average stress temperature is greater than or equal to the average stress forehead temperature for each breast to provide forehead to breast sector symmetry;

(x) determining using said determining means the difference between the number of sectors for each breast whose average stress temperature is greater than or equal to the average stress forehead temperature to provide forehead to breast differential sector asymmetry;

(xi) determining the number of sectors for each breast whose average temperature is less than the nipple average temperature during the stress scan and then taking the difference between the number for each breast to compute nipple rank;

(xii) determining the amount of cooling which occurs as a result of the stress by taking the difference between the average temperature per sector during a static scan minus the average temperature per sector during the stress scan, wherein minimum cooling is the lowest value and maximum cooling is the highest value;

whereby said is determined by adding the parameters determined in steps (v) through (xii).

9. The method of claim 8 wherein said temperature measurement means comprises a detector responsive to thermal radiation, and said temperature measurements of said breasts are made by passing said detector over said sectors in a predetermined sequential order, each sector being scanned for at least five seconds.

10. The method of claim 8 having the additional steps of comparing said worst breast average asymmetry with predetermined parameters using said determining means;

and

if said worst breast average asymmetry is greater than 6, subtracting 6 from said worst breast average asymmetry and multiplying the difference by 3 to provide a first number, and

if the worst breast average asymmetry is greater than 8, subtracting 8 from the worst breast average asymmetry, multiplying by 3, and adding to said first number.

11. The method of claim 8 having the additional steps of determining with said determining means, said contralateral asymmetry such that if the contralateral asymmetry is less than 7, substracting 7 from the contralateral asymmetry and multiplying by 2 to compute a first number, if the contralateral asymmetry is greater than 12, subtracting 12 from the contralateral asymmetry and multiplying by 3 to compute a second number, and if the contralateral asymmetry is greater than 15, subtracting 15 from the contralateral asymmetry, multiplying by 2, and adding to said second number.

12. The method of claim 8 having the additional step of computing a third parameter to be added to the basic parameter such that if said forehead to breast differential sector asymmetry is less than 3, multiplying said forehead to breast differential sector asymmetry by 2, and if said forehead to breast differential sector asymmetry is greater than 3, subtracting 3 from the forehead to breast differential sector asymmetry, multiplying by 3, adding to said first number.

13. The method of claim 8 having the additional steps of determining a fifth parameter such that if the nipple rank is greater than 3, subtracting 3 from the nipple rank, and multiplying by 3.

14. The method of claim 8 having the additional step of determining a fixed parameter such that if the maximum cooling is less than 4, subtracting 4 from the maximum cooling, and multiplying by four, and if the maximum cooling is greater than 8, subtracting 8 from the maximum cooling and multiplying by two.

15. The method of claim 8 having additional steps of determining a seventh parameter wherein if the minimum cooling is greater than 2, subtracting 2 from the minimum cooling and multiplying by three to provide a first number, and if the minimum cooling is greater than five, subtracting 5 from the minimum cooling and adding to said first number.

16. The method of claim 8 having the additional steps of computing said probability such that if the probability is less than 1 it is reported as 1, if greater than 80 then the result is compressed according to a logarithmic scheme, the maximum value being set as 99.

17. The method of claim 8 having the additional steps of:

(i) comparing said worst breast average asymmetry with predetermined parameters using said determining means, and if said worst breast average asymmetry is greater than 6, subtracting 6 from said worst breast average asymmetry and multiplying the difference by 3 to provide a first number, and if the worst breast average asymmetry is greater than 8, subracting 8 from the worst breast average asymmetry, multiplying by 3, and adding to said first number;

(ii) determining with said determining means said contralateral asymmetry such that if the contralateral asymmetry is less than 7, subtracting 7 from the contralateral asymmetry and multiplying by 2 to compute a first number, if the contralateral asymmetry is greater than 12, subtracting 12 from the contralateral asymmetry and multiplying by 3 to compute a second number, and if the contralateral asymmetry is greater than 15, subtracting 15 from the contralateral asymmetry, multiplying by 2, and adding to said second number;

(iii) computing a third parameter to be added to the basic parameter such that if said forehead to breast differential sector asymmetry is less than 3, multiplying said forehead to breast differential sector asymmetry by 2, and if said forehead to breast differential sector asymmetry is greater than 3, subtracting 3 from the forehead to breast differential sector asymmetry, multiplying by 3, adding to said first number; and

(iv) determining a fifth parameter such that if the nipple rank is greater than 3, subtracting 3 from the nipple rank and multiplying by 3;

adding the parameters of steps (i), (ii), (iii), and (iv) to said basic parameter to compute a raw probability such that if the raw probability is greater than 80, the probability will be determined by subtracting 80 from said raw probability, dividing by 25, adding 80, and taking the square root of the difference between the raw score and 80, and if the raw score is greater than 99, then the probability will equal 99.

18. The method of claim 1 wherein said organism is a human being, said first body portion comprising the left and right breasts of said body, each of which is imaginarily divided into eight radial sectors with the nipple thereof constituting a separate centrally disposed sector, and said temperature measurements are made of said radial sectors in a predetermined sequence.

19. The method of claim 18 wherein said average temperatures for the central sector nipple, the forehead, and each and every radial sector, comprises every combination of four consecutive data points within each area which are averaged together such that the highest running four point data average is considered to be the average temperature of the sector, nipple, or forehead.

20. The method of claim 1 having the additional step of providing a microprocessor means and an operator for detecting errors in the input and output of data by:

(i) converting the analog temperature data to digital form;

(ii) storing the measured data in digital form;

(iii) selecting the most representative data;

(iv) storing the selected data in electronic memory and displaying it on a video screen;

(v) checking the video screen by the operator to observe whether any pertinent measurements are incomplete, out of sequence, unrecorded or clearly erroneous, such that the operator will become alerted to the non-standard performance;

(vi) correcting the error.